An ongoing dialogue on HIV/AIDS, infectious diseases, all matters medical, and some not so medical.

September 17th, 2017

Subunit Zoster Vaccine Soon to Be Approved — Should Patients Wait for It?

Man with herpes zoster, 1893. National Library of Medicine.

For the last year or so, conversations with patients about getting the zoster vaccine have gone something like this:

Patient: So should I get the shingles vaccine? I saw an ad for it on TV.Me: Well, yes … and no.Patient (confused — he/she has never heard me say anything but an enthusiastic “Yes!” to vaccines): What does that mean?Me: There’s a better shingles vaccine coming soon, likely within a year. So I’d wait.

Now it looks like that wait is almost over.

This past week, an FDA advisory panel voted unanimously that the investigational subunit zoster vaccine is safe and effective for adults older than 50. The materials the panel reviewed are here.

FDA approval should follow soon — potentially next month — along with the critical review and recommendations from the Advisory Committee on Immunization Practices (ACIP).

The expert advisory panel based their decision on two pivotal randomized trials, ZOE-50 and ZOE-70, which compared the vaccine (administered as two doses) to placebo in people aged 50 and older or 70 and older, respectively. The studies enrolled nearly 30,000 subjects.

Vaccine efficacy was 97% in the first study, 89% in the second. The incidence of post-herpetic neuralgia was also reduced.

Importantly, adverse events were more common in vaccine recipients, but most were of mild severity. There was no significant difference in the incidence of severe side effects, deaths, or autoimmune processes.

Though these studies were not a direct comparison with the currently available live-attenuated zoster vaccine (Zostavax), remember that the efficacy of that vaccine is only around 50%.

That Zostavax is a live-virus vaccine creates additional difficulties. There is understandable concern — and confusion — about giving it to people with defects in cell-mediated immunity, for whom it’s contraindicated, and their household contacts, for whom it isn’t.

Finally, there are the practical difficulties of storing it before administration. Even clinics that do lots of immunizations — ours, for example — don’t have the required stand-alone freezer for storage of this vaccine. Many patients currently need to go to a pharmacy to get it, which adds an additional required step.

So this inactivated zoster vaccine won’t be just a “me-too” approval, but a real advance in prevention of what can be a truly debilitating condition. With the caveat that we lack safety data in very large patient populations — that should come after licensing — I’m not surprised the advisory panel voted the way they did.

It was exciting enough that I felt inspired to relay the following:

Big news because1) Highly effective2) Safe3) Not live attenuated5) Shingles can be BAD5) Have been telling my pts about it for months! https://t.co/4HJrK0wNAo

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21 Responses to “Subunit Zoster Vaccine Soon to Be Approved — Should Patients Wait for It?”

The huge question will be: is this approved for those immunocompromised patients such as cancer, RA on DMARDs and HIV. And, should those already immunized with the live Zostavax, receive the newer, more effective vaccine?

As always, Dr.Sax’s comments blend scientific rigor with real world wisdom and humor.
Blog didn’t address, and perhaps couldn’t address, insurance coverage. My practice is predominantly poor or working class, and while I can often overcome misapprehensions, I can’t get patients to receive any “optional” vaccine without 100% assurance that they won’t get stuck with out of pocket costs of hundreds of dollars.
Those costs wouldn’t break my bank, or yours, but quite literally could for patients whose disposable family income runs 1000-3000/month, the range into which most of my patients fall.

Thanks, Paul. This is great news for a lot of reasons. I’m assuming we will be able to give it to immunocompromised patients, unlike the attenuated live virus vaccine. I wonder if ACIP will once again recommend it be given to patients over 60, instead of the FDA-approved age 50, as was the case with Zostavax. (Thus creating commercial insurance reimbursement problems.) Medicare’s reimbursement will also be something to watch — will it also be a Part D medication, and not a Part B vaccination? We’ll see.

Because Zostavax protection wanes in about five years, the new vaccine from GSK should be highly recommended. Also, since it is not a live vaccine and has already been tested for, use by immunocompromised individuals should not cause any problems.
As a Ramsay Hunt Syndrome survivor, I will gladly go to the head of the line and pay out of pocket for Shingrix when it becomes available to the public. Having had Shingles in my ear once is enough for me.

This “mature” ID doc voted with my feet to wait about a year for the new vaccine. I gave my colleagues and wife the same advice for all the reasons listed here. Studies on immunogenicity of the adjuvanted subunit vaccine in transplant and other immunocompromised patients are coming out. A number of them will be presented at IDWeek 2017 so come on out to San Diego (Paul inspired me to make shameless plugs for meetings…)